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Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT00170222
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 29, 2008
Sponsor:
Information provided by:
Medical Center Alkmaar

Brief Summary:

The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.

The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: doxycycline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients
Study Start Date : July 2002
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Doxycycline
U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical efficacy at the end of treatment

Secondary Outcome Measures :
  1. Treatment failure at follow up
  2. Number of exacerbation


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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute exacerbation of COPD type I or II according to GOLD
  • Ability to perform lung function tests
  • Ability to take oral medication

Exclusion Criteria:

  • Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
  • Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation.
  • Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation.
  • Progression or new radiographic abnormalities on the chest X-ray.
  • Severe exacerbation that required mechanical ventilation.
  • History of bronchiectasis
  • Recent or unresolved lung malignancy.
  • Other disease likely to require antibiotic therapy.
  • Significant gastrointestinal or other conditions that may affect study drug absorption.
  • Class III or IV congestive heart failure or stroke.
  • Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).
  • Cystic fibrosis
  • Tuberculosis.
  • Impaired renal function (creatinine clearance < 20 ml/min).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170222


Locations
Netherlands
Medisch centrum Alkmaar
Alkmaar, Noord-holland, Netherlands, 1815 JD
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
Principal Investigator: Johannes MA Daniels, drs Pulmo Science
Principal Investigator: Dominic Snijders, drs Pulmo Science

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00170222     History of Changes
Other Study ID Numbers: M02-007
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008

Keywords provided by Medical Center Alkmaar:
Acute bronchitis
antibiotics

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Doxycycline
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents